Third-space endoscopic myotomy, including peroral endoscopic myotomy (POEM), gastric peroral endoscopic myotomy (G-POEM), Zenker’s peroral endoscopic myotomy (Z-POEM), and diverticular peroral endoscopic myotomy (D-POEM), is increasingly used for the treatment of gastrointestinal motility and diverticular disorders. However, substantial heterogeneity exists in the selection, definition, measurement, and timing of reported outcomes, including technical success, clinical success, adverse events, physiologic outcomes, patient-reported outcomes, recurrence, and reintervention. This variability limits comparison between studies and evidence synthesis.
A systematic methodological review will first identify and characterize outcomes reported in studies of POEM, G-POEM, Z-POEM, and D-POEM. Candidate outcomes will then undergo an international modified Delphi process involving healthcare professionals, researchers, methodologists, and patients/patient representatives, followed by a consensus meeting.
An ongoing COS is being developed for procedural interventions in adults with achalasia. This overlaps with our project specifically in relation to POEM for achalasia; however, its scope is condition-based and includes procedural treatments for achalasia, whereas our project focuses specifically on third-space endoscopic myotomy across multiple conditions, including gastroparesis and diverticular disorders. G-POEM, Z-POEM, and D-POEM and their condition-specific outcomes are outside the scope of the existing achalasia COS. A pediatric achalasia COS also exists but addresses a different age population.
Our project is therefore intended to complement rather than duplicate these COS initiatives. We propose a single overarching COS for third-space endoscopic myotomy, consisting of a common core of outcomes applicable across the procedures, supplemented by procedure- or condition-specific outcomes where required. The final composition of the common core and procedure-specific components will be determined through the Delphi and consensus process.
Sarah S. Al Ghamdi- King Abdulaziz University, Jeddah, Saudi Arabia
Jenan Ghaith- Cleveland Clinic Abu Dhabi, United Arab Emirates
Pradeep Bhandari- University of Portsmouth, United Kingdom
Disease Category: Gastroenterology
Disease Name: Gastrointestinal motility and diverticular disorders
Age Range: 14 - 100
Sex: Either
Nature of Intervention: Procedure
- Clinical experts
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
- Systematic review
A systematic methodological review will identify and characterize outcomes reported in clinical studies of POEM, G-POEM, Z-POEM, and D-POEM, including their definitions, measurement instruments, thresholds, and assessment time points. These findings will inform a candidate outcome list for an international modified Delphi process involving healthcare professionals, researchers, methodologists, and patients/patient representatives. Outcomes will be rated over at least two Delphi rounds using a 9-point scale, followed by a consensus meeting to determine the final Core Outcome Set, comprising common core outcomes and procedure- or condition-specific outcomes where appropriate.